Irish Medicines Board
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Ralgex Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ralgex Cream contains: Glycol Monosalicylate Methyl Nicotinate Capsicum Oleoresin
10.0 % w/w 1.0 % w/w 0.12 % w/w
Excipients: Contains Methylhydroxybenzoate (E218) Butylhydroxybenzoate (E216) Emulsifying wax (contains cetostearyl alcohol)
0.20 %w/w 0.10 % w/w 9.0 % w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream Thick, off-white, homogeneous cream with a characteristic odour.
4 CLINICAL PARTICULARS 4.1 Therapeutic Indications
Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain.
4.2 Posology and method of administration
Adults and children aged 12 years and over After trial use, rub into the skin until absorbed. To be applied as required to the affected area. Repeat as necessary up to four times a day. Not to be used on children under 12 years except on medical advice. The elderly The normal adult directions for use can be followed.
4.3 Contraindications
Known hypersensitivity to salicylates or to any of the ingredients of the cream. Injuries involving broken skin.
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Date Printed 31/08/2011
CRN 2104570
page number: 1
Irish Medicines Board
4.4 Special warnings and precautions for use
Side effects include local irritation and occasionally allergic reactions. Do not apply near the eyes, mouth or on sensitive body areas.
If symptoms persist or the condition is aggravated, consult the doctor.
Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
No evidence of safety of this product has been determined in pregnancy. It is not necessary to contraindicate this product in pregnancy and lactation provided caution is exercised and the directions for use are followed. However, as with all medicines, the advice of a doctor should be sought before the product is used.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Mild irritations of the skin (reddening, burning sensations and rarely swelling) have been reported, which may become more severe. Rashes have also been rarely reported.
4.9 Overdose
Overuse would probably cause localised redness, swelling and burning sensations of the skin owing to the counterirritant effect of the product. Rashes may also develop. These should subside on withdrawal of the product, but occasionally may require treatment. Where this is indicated, relief would be obtained from gently swabbing the area with gauze or white lint soaked in vegetable oil. Rarely the application of a cream or ointment containing corticosteroid may be necessary.
It is most unlikely that even the most excessive use of this product would lead to sufficient percutaneous absorption of active ingredients to cause systemic effects.
In the case of accidental oral ingestion, the advice of a doctor should be sought.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other topical products for joint and muscular pain, ATC code: M02A.
Methyl nicotinate has a counter-irritant effect by a rubefacient action. It readily penetrates the cutaneous barrier to produce vasodilatation and elevation of skin temperature.
Capsicum oleoresin has a counter-irritant effect by producing irritation and a transient feeling of warmth.
Glycol monosalicylate provides the anti-inflammatory and analgesic action.
Clinical data demonstrate that Ralgex Cream provides rapid warming relief for muscular aches and pains.
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Date Printed 31/08/2011
CRN 2104570
page number: 2
Irish Medicines Board
5.2 Pharmacokinetic properties
Glycol monosalicylate and methyl nicotinate are readily absorbed percutaneously.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Emulsifying Wax (contains cetostearyl alcohol) Glycerol monostearate with polyoxyethylene stearate Oleyl Alcohol Dimeticone Methylhydroxybenzoate (E218) Butylhydroxybenzoate (E216) Goliath perfume SE 83.0502 Neutralaire D7 Deionised water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Two years.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
Flexible aluminium tubes (containing 5 g, 15g, 40g, 44g, 80g, 88g, 100g or 110g of product), internally lacquered and having a white polypropylene screw cap. The tubes may be contained in a boxboard carton. Not all pack sizes may be marketed.
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
No special requirements.
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Date Printed 31/08/2011
CRN 2104570
page number: 3
Irish Medicines Board
7 MARKETING AUTHORISATION HOLDER
SSL International Plc Venus 1 Old Park Lane Trafford Park Manchester M41 7HA United Kingdom
8 MARKETING AUTHORISATION NUMBER
PA 1138/12/1
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16 June 1992 Date of last renewal: 16 June 2007
10 DATE OF REVISION OF THE TEXT
September 2008
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Date Printed 31/08/2011
CRN 2104570
page number: 4

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